Senior Clinical Research Associate

Body

Full time (1 FTE)

2 year fixed term contract

Respected global research organisation

Make an impact on global health outcomes

‘The George’ is 700+ people focused on improving the health of millions of people worldwide. A medical research institute affiliated with leading universities and with projects in approximately 50 countries, we are challenging the status quo in healthcare to find the best ways to prevent and treat chronic disease and injury, and to influence policy and practice worldwide. Our innovative commercial enterprises help maximise our impact.

Just a sample of the things we’re doing to have the greatest impact on global health:

We are identifying better and safer treatments for our biggest killers like stroke, heart disease and high blood pressure

In many countries, our award winning FoodSwitch smartphone app is helping people make healthy food choices when shopping

We’ve shown that simple text messaging can help prevent heart attack and stroke. Now, we’re working with Google to roll this out globally to prevent chronic diseases affecting millions of people

In China, we ran a successful education and awareness program to reduce the amount of salt eaten by people by 25% each day

In rural India, we’ve shown that mobile technology can help diagnose mental health, as well as help treat cardiovascular disease, and we’re looking at similar approaches to treating chronic diseases in Indonesia and China

Together with Aboriginal communities in NSW, Australia, we’ve developed an innovative community led program to assist young Aboriginal drivers attain their license, now implemented in a dozen of locations

We’re developing an affordable dialysis machine, with potential to save millions of lives each year and transform the way kidney disease is treated globally

And much more...

An exciting opportunity exists for a Senior Clinical Research Associate (SCRA) to join our growing organisation.

The Senior Clinical Research Associate (SCRA) will support the Project Manager in the development and execution of various research projects (clinical and non-clinical trials) within the academic research programs of work. In addition to site management responsibilities, the SCRA will support the PM on project management-related tasks allocated to them.

Key responsibilities of the role will include:

Clinical Trial Start-up Phase:

Participate in the clinical trial feasibility assessment, identify and selects investigators with the PM

Site management responsibilities:

Prepares and ensure the Human Research Ethics Committee (HREC) submissions are completed within the project timelines

Prepares/collects all documents needed prior to study initiation

Conducts site initiation meetings to ensure compliance with SOP and all study specific and regulatory requirements are met

Develops and maintains a good working relationship with the Investigational site staff

Management of the local study files, including in-house and site file

Prepares, organises and participates in Investigator meetings

Site management:

Conduct on site and remote monitoring of participating centres to ensure:

Quality, accuracy, completion, and timeliness of data entry

Complete and efficient resolution of data issues and audit findings

Adherence to the study protocol and study procedures manual

Adherence to ICH/GCP and other regulatory guidelines and requirements as relevant to this trial, including reporting of adverse events/serious adverse events

Complete all monitoring visit and progress reports accurately and within study specified timeframe

Collect and review essential documents from study sites and ensure they are complete at study close-out and appropriately stored/managed in-house

Overseas regional co-ordinating centre management:

Manage and assist regional coordinating staff in the local management of the study where required

Affiliation/s

Social links Global

Acknowledgement of Country

The George Institute acknowledges the Gadigal People of the Eora Nation as the Traditional Custodians of the land on which our Australia office and Global Headquarters are built. We pay our respect to Elders past, present and emerging.